Preclinical Development – Chemical
2019 PharmSci 360
Applications of quantitative systems pharmacology (QSP) to pharmaceutical research and development (R&D) have gradually increased, as evidenced by the number of QSP publications in literature and in regulatory submissions. QSP applications to R&D are broad, including target identification, drug discovery, preclinical drug development, clinical drug development and post marketing applications (new indications, new dosing regimens). The US Food and Drug Administration has initiated model informed Drug Development and Comprehensive in-vitro proarrhythmia assay Initiative (CiPA); and continues to work with the stakeholders on applying QSP to guide drug development. The four speakers for this symposium will present QSP applications to pharmaceutical R&D, covering both efficacy and safety for several disease areas.